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Comparing Iovera Cryoneurolysis and Radiofrequency Ablation for Chronic Low Back Pain

This study is comparing two treatments for long-term (chronic) low back pain: Iovera Lumbar Medial Branch Cryoneurolysis and Radiofrequency Ablation (RFA). Iovera uses cold to target specific nerves, while RFA uses heat. The goal is to see which treatment is better at reducing your pain. You might be able to join if you are at least 18 years old and have chronic low back pain that seems to come from your facet joints. The study will measure your pain intensity using a Numeric Rating Scale (NRS) 360 days after your treatment to see how successful the treatments are. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 110 participants. You will be randomly assigned to receive either Iovera cryoneurolysis or radiofrequency ablation.
What's involved
You will receive one of the two treatments. The research team will check your pain levels and overall health for about 12 months after the procedure. The entire study will last about 14 months for each participant.
Compensation
Not stated in the trial record.
Follow-up
Your pain intensity will be measured 360 days (about 12 months) after your intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07214844

A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain

Recruiting
NAAges 18+InterventionalTreatment
Montefiore Medical Center
~110 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Iovera Medial Branch CryoneurolysisRadiofrequency ablation (RFA)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numeric rating scale (NRS) pain intensity score
Measured over 360 days after intervention

Conditions

Low Back Pain, Chronic

Explore related trials

Lower Back Pain

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Karina Gritsenko, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Karina Gritsenko, MD
[email protected]
609-369-0344
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subjects at least 18 years of age at Screening
Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative testing (e.g., axial loading, paraspinal tenderness)
Low back pain is chronic (i.e., ≥ 3 months' duration)
Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening
Low back pain causes functional impairment (≥ 30% on ODI) at Screening
Successful trial of two diagnostic medial branch blocks consisting of two positive blocks with local anesthetic only (i.e., no steroids) that results in at least 80% relief of primary (index) pain for the duration of the local anesthetic used
Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, sleep hygiene, weight loss, spinal injections, NSAIDs, physician-directed exercise program or other appropriate analgesics)
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment

Exclusion

Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine
Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following:
Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder
Currently pregnant, nursing, or planning to become pregnant during the study
Known contraindication to study device, including any of the following:
Severe chronic pain disorder that in the opinion of the investigator may impact study outcomes
Presence of any of the following:
Current manifestation of poorly controlled mental illness or catastrophizing that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following:
Subject received other spine intervention/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies) at the intended lumbar treatment levels
Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment at the intended lumbar treatment levels
Pain relief following diagnostic medial branch blocks lasted longer than the duration of the local anesthetic used (i.e., \> 24 hours)
Opioid abuse or dependence (≥40 mg medication PO/day in past 30 days)
Given the COVID-19 pandemic, the subject must be medically fit/cleared for surgery by the investigator. If there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness), the subject must be excluded.

What this trial measures

  • Numeric rating scale (NRS) pain intensity score360 days after intervention

    Subjects will evaluate their pain in the low back region using an 11-point NRS where 0=no pain and 10=worst possible pain, such that higher scores are associated with greater pain intensity. * Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, how much pain are you experiencing in your low back right now? * Pain intensity scores (using the numeric rating scale; NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the worst pain in your low back in the last 24 hours?" * Pain intensity scores (using the NRS) measured as "On a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, what was the average pain in your low back in the last 24 hours?" Mean numeric pain intensity rating scores will be summarized by study arm using basic descriptive statistics.